Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery

NCT06213805 | Completed

• 1 other identifier: 2023-A02193-42
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

The main objective is to evaluate the effectiveness of MIMS in patients with an indication for glaucoma surgery, compared to traditional surgery. The secondary objective is to assess safety. The investigating ophthalmologist will follow the patients and collect clinical data in order to identify the benefits and complications of MIMS. Patients are expected to experience fewer complications compared to traditional glaucoma surgery.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Measurement of intraocular pressure by tonometry

  Measure in millimeters of mercury (mmHg)

  day 0, day 7, day 14, day 30, month 6, month 9 and month 12 after surgery

Secondary Outcomes (3)

• visual quality of life VFQ-25,

  month 1, month 3, month 12 after surgery

• Optical Coherence Tomography

  month 3, month 12

• Visual field test

  month 3, month 12

Study Arms (1)

Minimally invasive microsclerostomy

EXPERIMENTAL

Procedure: Minimally invasive microsclerostomy

Interventions

Minimally invasive microsclerostomy PROCEDURE

MIMS is a filtering glaucoma surgery, which consists of creating a sclero-corneal drainage channel, to allow the flow of aqueous humor and therefore the reduction of intraocular pressure. This surgery is extremely quick, lasting 3 to 5 minutes, according to recent MIMS studies, in contrast to the duration of a trabeculectomy, the classic glaucoma surgery, which varies between 20 and 60 minutes.

Minimally invasive microsclerostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years old who agree to participate in the study having signed informed consent
• Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and open iridocorneal angle ( trabecular meshwork visible on gonioscopy, Shaffer classification grade 3-4) and healthy and mobile conjunctiva (without scars or adhesions).
• Chronic angle closure glaucoma with indication for combined glaucoma and cataract surgery

You may not qualify if:

• Presence of other ophthalmological pathologies (except cataract)
• History of intraocular surgery (unless cataract surgery), history of trauma, or conjunctival scarring in the quadrant planned for surgery
• Visual acuity lower than "counts fingers" ", closure of the iridocorneal angle (and angle-closure glaucoma unless associated cataract surgery), neovascular glaucoma or neovascularization of the iris, pachymetry \< 490 μm or \> 620 μm.
• Presence of severe systemic pathologies, pregnant or breastfeeding woman

Sponsors & Collaborators

• Hôpital Privé de la Baie: lead

Study Sites (3)

Hôpital Privé de la Baie

Avranches, 50300, France

Location

Clinique Thiers

Bordeaux, 33100, France

Location

Fondation Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Ana Miguel, MD

  Hôpital Privé de la Baie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 19, 2024
• Study Start: January 15, 2024
• Primary Completion: March 26, 2026
• Study Completion: March 26, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)